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Behavioural Intervention
Magnetic Stimulation for Stress Urinary Incontinence
N/A
Waitlist Available
Led By P Lee, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No concurrent or new planned treatment for SUI during the treatment period and the 3 months following it
Non-pregnant adult female, not planning pregnancy during the duration of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12 and 24 months post treatment
Awards & highlights
Study Summary
This trial tests an electric therapy to help women with leaking urine when they sneeze, cough, or exercise.
Who is the study for?
This trial is for adult females with stress urinary incontinence, who are not pregnant or planning pregnancy, without metal implants from umbilicus to knees. Participants should have no recent pelvic treatments and be able to follow the study protocol. Exclusions include those on current chemo/radiotherapy, with systemic diseases affecting bladder function, or other types of urinary incontinence.Check my eligibility
What is being tested?
The trial tests if electromagnetic stimulation can help women with stress urinary incontinence by strengthening their pelvic floor muscles. It compares real magnetic stimulation treatment against a sham (fake) procedure to see if there's an actual benefit.See study design
What are the potential side effects?
Potential side effects may include discomfort at the treatment site or muscle fatigue due to the stimulation process. Since it's non-invasive, serious side effects are unlikely but could involve skin irritation or temporary pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not planning any treatment for stress urinary incontinence soon.
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I am not pregnant and do not plan to become pregnant during the study.
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I can empty my bladder well and have minimal pelvic organ drop.
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My bladder can hold at least 200cc of urine.
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I have seen urine leak when I cough or strain with a partly full bladder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 12 and 24 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12 and 24 months post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ICIQ-SF (standardized, validated questionnaire)
Secondary outcome measures
24 hour pad test
ICIQ-LUTS-qol
IIQ-7
+3 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Magnetic stimulation therapyActive Control1 Intervention
Participants will sit fully clothed on the magnetic stimulator chair, with knees apart at about the width of their shoulders, feet flat on the floor. The stimulator will be activated and the intensity gradually increased as tolerated by the participant up to an intensity of 100%. There are a total of 6 treatment sessions (twice per week) over 3 weeks.
Group II: Sham therapyPlacebo Group1 Intervention
Participants will sit fully clothed on the magnetic stimulator chair, with knees apart at about the width of their shoulders, feet flat on the floor. The stimulator will be activated and the intensity gradually increased as tolerated by the participant up to an intensity of 5%. There are a total of 6 treatment sessions (twice per week) over 3 weeks.
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,464 Total Patients Enrolled
Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of OntarioUNKNOWN
1 Previous Clinical Trials
60 Total Patients Enrolled
P Lee, MDPrincipal InvestigatorSunnybrook Health Sciences Centre,, University of Toronto
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not planning any treatment for stress urinary incontinence soon.I am not pregnant and do not plan to become pregnant during the study.My pad weight increase is less than 3 grams in a 24-hour test.I am currently being treated for chronic pelvic pain.You have metal in your body from the waist to the knees, or a heart pacemaker.I cannot walk on my own without help or sit up by myself.I can empty my bladder well and have minimal pelvic organ drop.I am currently undergoing or have recently had chemo, radiotherapy, pelvic radiation, or pelvic surgery.I have a condition like Parkinson's or MS that affects bladder control.You do not have any metal in your body from your belly button to your knees.You have a different type of urinary incontinence, like urgency incontinence or overflow incontinence.You have had certain surgeries or treatments for bladder issues.I can follow the study's requirements and accurately report my medical history.My bladder can hold at least 200cc of urine.I have had stress urinary incontinence for 3 months or more.I have undergone magnetic stimulation therapy before.I have seen urine leak when I cough or strain with a partly full bladder.
Research Study Groups:
This trial has the following groups:- Group 1: Magnetic stimulation therapy
- Group 2: Sham therapy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this examination currently enrolling participants?
"Confirmed, the trial is actively recruiting according to clinicaltrials.gov records. The study was originally posted on July 10th 2023 and has been revised on July 18th of this year."
Answered by AI
How many subjects are contributing to this investigation?
"Indeed, information hosted on clinicaltrials.gov states that the trial is actively recruiting participants; with a post date of July 10th 2023 and an edit made as recent as July 18th 2023. Across one medical centre 158 patients are required for this study."
Answered by AI
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